Hydroxychloroquine Sulfate
- Product NDC
- 16571-112
- 11-digit product format
- 165710112
- Labeler code
- 16571
- Product ID
- 16571-112_40679f36-52b2-4c4f-9a83-cc0c136077ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA210959
- Marketing category
- ANDA
- Marketing start
- 2023-05-29
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxychloroquine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYCHLOROQUINE SULFATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8Q2869CNVH |
| Rxcui | 979092 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-112-01 | Hydroxychloroquine Sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 16571-112-06 | Hydroxychloroquine Sulfate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 16571-112-10 | Hydroxychloroquine Sulfate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 16571-112-50 | Hydroxychloroquine Sulfate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-112 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, 4 package rows | 20240517_6837f2aa-1349-4b45-a0ac-09ec914fd764.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-112-01 | 16571011201 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-112-01) | 2023-05-29 | No | No | Current |
| 16571-112-06 | 16571011206 | 60 TABLET, FILM COATED in 1 BOTTLE (16571-112-06) | 2023-05-29 | No | No | Current |
| 16571-112-10 | 16571011210 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-112-10) | 2023-05-29 | No | No | Current |
| 16571-112-50 | 16571011250 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-112-50) | 2023-05-29 | No | No | Current |